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FirstHealth Clinical Trial to Study Cancer-Related Insomnia Therapies

| Date Posted: 8/8/2016

Charles D. Kuzma, M.D.

PINEHURST – According to the National Cancer Institute, an estimated one-third to one-half of people with cancer experience some kind of sleep disturbance.

That’s not surprising, says Lori Despain, R.N., of the FirstHealth Clinical Trials program. Insomnia is a common side effect of many medications that are used in cancer treatment. Anxiety and “fear of the unknown” are also known to contribute to sleep disturbance.

“Sleep is a big part of healing,” Despain says. “When it is impaired, it can really impact a patient’s overall well-being.”

As part of a national study approved by the Research Subjects Review Board (RSRB) at the University of Rochester (New York), FirstHealth Clinical Trials is now enrolling local cancer survivors in a clinical trial designed to determine the effectiveness of three non-medication therapies in the treatment of cancer-related insomnia. Selected participants will be randomly assigned to one of three different study “arms”: yoga, survivorship health education and Cognitive Behavioral Therapy (counseling).

About 630 cancer patients from across the U.S. will take part in the study with a maximum of 30 (10 in each arm) coming from FirstHealth. One group will participate in yoga (Gentle Hatha and Restorative) twice a week for four weeks, and the second will attend health education sessions two times a week for four weeks. The third group will attend a counseling session once a week for eight weeks.

According to Despain, it will take about nine months to complete all of the assessments involved in the study.

“This will be a totally randomized trial,” she says. “We don’t choose which arm the patient participates in. That’s completely done by the research base, which is true of all of our trials.”

Among other criteria, participants must have moderate to severe sleep problems and have completed cancer treatment within the last two to 24 months. They must also be at least 18 years of age.

More than 200 patients are now actively involved in or are being followed in FirstHealth Clinical Trials studies. Thirty-three studies are currently open and enrolling, and about the same number are ongoing but are no longer accepting patients.

About 98 percent of the FirstHealth studies are related to cancer with the others involving heart or pulmonary disease.

Charles D. Kuzma, M.D., a medical oncologist and physician champion for the FirstHealth Clinical Trials program, says clinical trials have an important place in disease treatment.

“FirstHealth offers clinical research trials to a variety of patients,” he says. “These trials are critical to helping advance medicine and potentially finding cures for serious diseases such as cancer. The insomnia trial we are offering is part of the comprehensive cancer services offered at Moore Regional and is focused on helping cancer patients deal with a common side effect of their treatments. We are excited to be offering this trial and to partner with many other community cancer centers around the country to further help cancer patients.”

If you are interested in participating in the cancer and insomnia study to be conducted by FirstHealth Clinical Trials, or if you have questions about the study, contact the FirstHealth research team at 1-888-534-5333.